COVID-19 EUA Recipient/Caregiver VIS Code Set update April 6, 2021
The CDC VIS Code Set incorporates codes for COVID-19 vaccine Emergency Use Authorization (EUA) Recipient/Caregiver Fact Sheets.
CDC Authored VIS documents will not be available for COVID-19 vaccines while under Emergency Use Authorization. Under EUA, the FDA requires a vaccine-specific Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to Vaccine Information Statements for licensed vaccines). Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA. The COVID-19 vaccine related codes in this code set release are provided in anticipation of potential vaccine availability under Emergency Use Authorization. If the vaccines are not authorized, these codes will be retired.
Release Notes: This document provides a summary of the Vaccine Information Statement (VIS) code updates and maps as of 04/06/2021.
The following COVID-19 Vaccine EUA Recipient/Caregiver Fact sheet update is addressed in this release:
- Moderna COVID-19 Vaccine – New Edition of the EUA Recipient/Caregiver Fact Sheet dated 03/26/2021
- Janssen (J&J) COVID-19 Vaccine - New Edition of the EUA Recipient/Caregiver Fact Sheet dated 03/19/2021
Note that Janssen did not create a new Document Barcode String for the New Edition - COVID-19 Pfizer BioNTech Vaccine - EUA Recipient-Caregiver Fact Sheet dated 4/6/2021
Note that Janssen did not create a new Document Barcode String for the New Edition
EUA Recipient/Caregiver Fact Sheet Description | Document Barcode String | Edition Date | Edition Status | VIS GDTI document code |
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COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet | 253088698300034911201201 | 12/01/2020 | Historic | 0886983000349 |
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COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet | 253088698300034911210401 | 3/26/2021 | Current | 0886983000349 |
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COVID-19 Janssen Vaccine EUA Recipient-Caregiver Fact Sheet | 253088698300036311210201 | 3/19/2021 | Current | 0886983000363 |
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COVID-19 Pfizer BioNTech Vaccine EUA Recipient-Caregiver Fact Sheet | 253088698300033211201201 | 4/6/2021 | Current | 0886983000363 |
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The above updates impact the following VIS code files and tables:
- CVX Mapped to VIS
- VIS Barcode Lookup Table
- VIS URLs
Additional COVID-19 Special Releases with advance preview codes will be provided as other COVID-19 vaccines near their Emergency Use Authorization request submissions to FDA, or as manufacturers update their EUA Fact Sheets.
Important Considerations:
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) in electronic medical records/immunization information systems. As such, the VIS code set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EHRs/EMRs for use in a manner analogous to the electronic system and workflow documentation of VIS. As with VIS documents, the COVID-19 Vaccine Recipient/Caregiver Fact Sheets may incorporate the CDC’s scannable 2D barcode in the Fact Sheet document. The numeric string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.
